fluconazole

Generic: fluconazole

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluconazole
Generic Name fluconazole
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fluconazole 150 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-119
Product ID 68462-119_639b832d-b798-4efb-8db0-e64b8ba81574
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077253
Listing Expiration 2027-12-31
Marketing Start 2020-11-20

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 2c19 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462119
Hyphenated Format 68462-119

Supplemental Identifiers

RxCUI
197698 197699 197700 197701
UPC
0368462119440 0368462119402 0368462102305 0368462104309 0368462101308
UNII
8VZV102JFY
NUI
N0000175487 M0002083 N0000182140 N0000182141 N0000185504

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluconazole (source: ndc)
Generic Name fluconazole (source: ndc)
Application Number ANDA077253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68462-119-40) / 1 TABLET in 1 BLISTER PACK
  • 12 BLISTER PACK in 1 CARTON (68462-119-44) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

68462-119-40 1 BLISTER PACK in 1 CARTON (68462-119-40) / 1 TABLET in 1 BLISTER PACK 68462-119-44 12 BLISTER PACK in 1 CARTON (68462-119-44) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

fluconazole (150 mg/1)

Linked Drug Pages (1)

Fluconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "639b832d-b798-4efb-8db0-e64b8ba81574", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504"], "upc": ["0368462119440", "0368462119402", "0368462102305", "0368462104309", "0368462101308"], "unii": ["8VZV102JFY"], "rxcui": ["197698", "197699", "197700", "197701"], "spl_set_id": ["3da5f41d-5200-45ac-b89d-00881237ec85"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68462-119-40)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "68462-119-40", "marketing_start_date": "20201120"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (68462-119-44)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "68462-119-44", "marketing_start_date": "20201120"}], "brand_name": "Fluconazole", "product_id": "68462-119_639b832d-b798-4efb-8db0-e64b8ba81574", "dosage_form": "TABLET", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]"], "product_ndc": "68462-119", "generic_name": "Fluconazole", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluconazole", "active_ingredients": [{"name": "FLUCONAZOLE", "strength": "150 mg/1"}], "application_number": "ANDA077253", "marketing_category": "ANDA", "marketing_start_date": "20201120", "listing_expiration_date": "20271231"}